Efferon LPS Hemoadsorption in in Patients With Thermal Burns

Extracorporeal Blood Purification Using Efferon LPS Hemoadsorption in Patients With Thermal Burns: Pilot Study

The aim of the study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoadsorption using the Efferon® LPS device to reduce the severity of clinical symptoms and to prevent the progression of multiple organ dysfunction or to arrest its development in patients with burn disease with an RFI score ≥71 and ≤181.

Patients will be randomized in two groups: control group receiving baseline therapy (including CRRT) and treatment group receiving baseline therapy and Efferon® LPS hemoadsorption in combination with CRRT.

Study Overview

• Status: Not yet recruiting
• Conditions: Burns
• Intervention / Treatment: Device: Efferon LPS

Detailed Description

Extensive burns are a severe form of trauma that, according to the World Health Organization, cause more than 180,000 deaths worldwide each year. Burn injury is not only a local tissue injury at the site of the damaging agent, but also triggers a complex systemic response to trauma. Severe burn injury induces a systemic inflammatory response associated with generalized microcirculatory disturbances in organs and tissues, cellular dystrophy and destruction, and the development of multiple organ dysfunction and failure. Burn trauma causes massive release of damage-associated molecular patterns (DAMPs) and pro-inflammatory cytokines, leading to systemic inflammatory response syndrome (SIRS), which may result in multiple organ failure and death. Mortality associated with multiple organ failure in burn patients reaches 81-87% among patients who develop this condition, and multiple organ failure remains the leading cause of death in burn patients. Among patients with a Sequential Organ Failure Assessment (SOFA) score ≥4 within the first 24 hours after injury, mortality reaches 81%.

The Efferon LPS hemoadsorption device was developed for use in sepsis, leveraging its ability to effectively target both primary and secondary inflammatory mediators. However, this approach also has significant potential in the treatment of burn injury, a condition characterized by a complex inflammatory response.

The goal of this study is to evaluate the safety and efficacy of multimodal (cytokine and lipopolysaccharide) hemoadsorption using the Efferon LPS device to reduce the severity of clinical manifestations and to prevent progression of multiple organ dysfunction, or mitigate it if already developed, in patients with burn disease and an RFI score ≥71 and ≤181.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alexandr Shelehov-Kravchenko, PhD, MD; Phone Number: +79636564765; Email: ais@efferon.ru

Study Locations

• Russia
  • Moscow, Russia, 129090
    • N.V. Sklifosovsky Research Institute for Emergency Medicine
    • Contact: Vladimir Kulabukhov, PhD, MD; Phone Number: +79255068081; Email: v.kulabukhov@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Thermal burns (flame, scald, or contact burns), including cases combined with inhalation injury
• Revised Frank Index (RFI) score ≥71 and ≤181
• Indication for extracorporeal therapy within the first 10 days after injury
• The patient's condition allows Efferon LPS therapy to be performed for at least 6 hours

Exclusion Criteria:

• Isolated thermal-inhalation injury
• Chemical, electrical, or solar burns of the skin
• Combined skin burns with frostbite and/or general hypothermia
• Combined trauma (electrical injury; traumatic brain injury other than concussion or mild cerebral contusion; skull, spinal, thoracic, pelvic, or femoral fractures) or acute pre-existing pathology prior to hospital admission (acute myocardial infarction, stroke, community-acquired pneumonia, or acute surgical conditions) that may influence the course and outcome of burn disease
• Cardiopulmonary resuscitation at the pre-hospital stage
• End-stage renal disease
• Acute pulmonary embolism confirmed by imaging
• Emergency surgical treatment
• Any other condition which, in the investigator's opinion, precludes inclusion of the patient in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline therapy; Patients receiving standard treatment for the treatment of thermal burns without the use of hemoadsorption methods, but who are prescribed continuous renal replacement therapy (CRRT) for renal and non-renal indications.
Experimental: Baseline therapy + Efferon LPS; Patients receiving standard therapy for the treatment of thermal burns, along with Efferon LPS hemoadsorption procedures in combination with continuous renal replacement therapy (CRRT).	Device: Efferon LPS; Efferon LPS, a medical device, which is a single-use cartridge filled with a polymeric adsorbent that selectively adsorbs endotoxin via surface-immobilized ligand and excessive cytokines via its intrinsic porosity.hemoadsorption procedures, each lasting 6-12 hours, with an interval of at least 24 hours between hemoadsorption sessions (from the start of the first procedure). The procedures are performed in combination with continuous renal replacement therapy (CRRT).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for vasopressor support	Need for vasopressors according to the Vasoactive inotropic score (VIS 2020) heart rate scale. VIS is calculated as a weighted sum of all administered vasoactive inotropic agents.	1-28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Horowitz oxygenation index	Value of oxygenation index (Pa02 / Fi02 (Pa).	1-28 days
Renal replacement therapy (RRT) free days	RRT-free days = 0 if the subject dies within 28 days of starting renal replacement therapy. RRT-free days = 28 - x if RRT is successfully discontinued x days after initiation. RRT-free days = 0 if the subject requires RRT for more than 28 days.	1-28 days
28 and 60 days mortality	Mortality rate	1-60 days
Length of stay in the intensive care unit	Time (number of days) from study enrollment to transfer from the intensive care unit within 60 days	1-60 days
Duration of hospitalization	Time (number of days) from study enrollment to discharge from the hospital	1-60 days
Frequency of septic complications	Percentage of patients with septic complications	1-28 days
Frequency of surgical interventions	Percentage of patients requiring surgery	1-28 days

Collaborators and Investigators

• Sponsor: Efferon JSC
• Investigators: Principal Investigator: Vladimir Kulabukhov, PhD, MD, N.V. Sklifosovsky Research Institute for Emergency Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): February 27, 2028

Study Registration Dates

• First Submitted: April 28, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Hemoperfusion; Hemoadsorption; LPS adsorption; Extracorporeal therapy
• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: efferon-lps-2026-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No